A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children

Summary

The purpose of this study is to see if it is safe to give Varivax to HIV-positive children
and whether it protects children from infection. Varivax is a vaccine against varicella
zoster virus (VZV), the virus that causes chickenpox (varicella) and shingles (zoster).

VZV can cause many serious complications in HIV-infected children. Varivax is a VZV vaccine
that has been approved for use in healthy children. More research is needed to find out how
this vaccine will affect HIV-infected children.

Description

Primary varicella infection, or chickenpox, can be devastating to HIV-infected children
because complications occur at higher rates in immunocompromised hosts. Current passive
prophylaxis measures with varicella-zoster immune globulin are suboptimal because
administration must be repeated for each exposure during the child's lifetime and timely
notification of exposure is not always possible. Since Varivax has been licensed for routine
vaccination of healthy individuals, it must be determined whether this vaccine can be safely
administered to HIV-infected children.

Thirty-six children who are varicella zoster virus (VZV)-naive (treatment group) receive
Varivax at Weeks 0 and 12, with a possible boost at Week 52 if the patient is still
seronegative for VZV and cytomegalovirus infection. Twenty children who have a history of
wild-type varicella exposure within the past year (control group) receive no study
treatment. All patients are either asymptomatic or mildly symptomatic for HIV infection.
Patients make 12-14 visits to the clinic. [AS PER AMENDMENT 9/9/99: This study has been
reorganized into two cohorts (asymptomatic and symptomatic). In the asymptomatic cohort,
accrual has been completed with 40 patients in Treatment Group I and 19 in the control
group. This phase of the study demonstrated that Varivax was well tolerated in 48
HIV-infected children with asymptomatic disease. The symptomatic cohort includes Treatment
Groups II and III, each with 30 patients. The first 10 patients from Group II are monitored
for 42 days following the first dose of vaccine before the remaining 20 are accrued. Once
the first 10 patients in Group II have been evaluated with acceptable toxicity and
immunologic profiles, the remaining 20 Group II and the first 10 Group III patients are
enrolled. The first 10 Group III patients are also followed for acceptable toxicity and
immunologic response before accrual of the remaining 20 Group III patients.]

Varicella-zoster virus (VZV) is under consideration as a promising recombinant viral vector to deliver foreign antigens including HIV. However, new vectors have come under increased scrutiny since vac...

The varicella-zoster virus does double-duty: It can cause chickenpox when you're young and reactivate later in life as a painful, blistery rash called shingles. Well, there's a vaccine for each diseas...

Medical and Biotech [MESH] Definitions

Chickenpox Vaccine

A live, attenuated varicella virus vaccine used for immunization against chickenpox. It is recommended for children between the ages of 12 months and 13 years.

Mumps Vaccine

A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had mumps or been immunized with live mumps vaccine. Children are usually immunized with measles-mumps-rubella combination vaccine.

Measles Vaccine

A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had measles or been immunized with live measles vaccine and have no serum antibodies against measles. Children are usually immunized with measles-mumps-rubella combination vaccine. (From Dorland, 28th ed)

Smallpox Vaccine

A live VACCINIA VIRUS vaccine of calf lymph or chick embryo origin, used for immunization against smallpox. It is now recommended only for laboratory workers exposed to smallpox virus. Certain countries continue to vaccinate those in the military service. Complications that result from smallpox vaccination include vaccinia, secondary bacterial infections, and encephalomyelitis. (Dorland, 28th ed)

Vaccinia Virus

The type species of ORTHOPOXVIRUS, related to COWPOX VIRUS, but whose true origin is unknown. It has been used as a live vaccine against SMALLPOX. It is also used as a vector for inserting foreign DNA into animals. Rabbitpox virus is a subspecies of VACCINIA VIRUS.

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